Search: WFRF:(Graf Wilhelm)
> (2015-2019)
> Wexner S >
Libertas :
Libertas : a phase II placebo-controlled study of NRL001 in patients with faecal incontinence showed an unexpected and sustained placebo response
-
- Siproudhis, L. (author)
- CHU Pontchaillou, Rennes, France.
-
- Graf, Wilhelm (author)
- Uppsala universitet,Kolorektalkirurgi
-
- Emmanuel, A. (author)
- Univ Coll Hosp, 235 Euston Rd, London, England.
-
show more...
-
- Walker, D. (author)
- Norgine Ltd, Norgine House,Widewater Pl,Moorhall Rd, Uxbridge UB9 6NS, Middx, England.
-
- Shing, R. Ng Kwet (author)
- Norgine Ltd, Norgine House,Widewater Pl,Moorhall Rd, Uxbridge UB9 6NS, Middx, England.
-
- Pediconi, C. (author)
- Norgine Ltd, Norgine House,Widewater Pl,Moorhall Rd, Uxbridge UB9 6NS, Middx, England.
-
- Pilot, J. (author)
- Norgine Ltd, Norgine House,Widewater Pl,Moorhall Rd, Uxbridge UB9 6NS, Middx, England.
-
- Wexner, S. (author)
- Cleveland Clin Florida, Weston, FL USA.
-
- Scholefield, J. (author)
- Univ Nottingham Hosp, Div Surg, Nottingham NG7 2UH, England.
-
show less...
-
CHU Pontchaillou, Rennes, France Kolorektalkirurgi (creator_code:org_t)
- 2016-04-13
- 2016
- English.
-
In: International Journal of Colorectal Disease. - : Springer Science and Business Media LLC. - 0179-1958 .- 1432-1262. ; 31:6, s. 1205-1216
- Related links:
-
https://doi.org/10.1...
-
show more...
-
https://uu.diva-port... (primary) (Raw object)
-
https://link.springe...
-
https://urn.kb.se/re...
-
https://doi.org/10.1...
-
show less...
Abstract
Subject headings
Close
- Faecal incontinence (FI) is distressing, significantly reduces quality of life (QoL) and has few pharmacological treatments. The alpha(1)-adrenoceptor agonist NRL001 (1R,2S-methoxamine hydrochloride) improves anal sphincter tone. NRL001 efficacy was evaluated by changes in Wexner scores at week 4 vs. baseline in NRL001-treated patients compared with placebo. Impact of NRL001 on QoL and safety were also assessed. Four hundred sixty-six patients received NRL001 (5, 7.5 or 10 mg) or placebo as suppository, once daily over 8 weeks. Wexner score, Vaizey score and QoL were analysed at baseline, week 4 and week 8. FI episodes and adverse events were recorded in diaries. At week 4, mean reductions in Wexner scores were -3.0, -2.6, -2.6 and -2.4 for NRL001 5, 7.5, 10 mg and placebo, respectively. All reduced further by week 8. As placebo responses also improved, there was no significant treatment effect at week 4 (p = 0.6867) or week 8 (p = 0.5005). FI episode frequency improved for all patients, but not significantly compared with placebo (week 4: p = 0.2619, week 8: p = 0.5278). All patients' QoL improved, but not significantly for all parameters (p > 0.05) except depression/self-perception at week 4 (p = 0.0102) and week 8 (p = 0.0069), compared with placebo. Most adverse events were mild and judged probably or possibly related to NRL001. All groups demonstrated improvement in efficacy and QoL compared with baseline. NRL001 was well-tolerated without serious safety concerns. Despite the improvement in all groups, there was no statistically significant treatment effect, underlining the importance of relating results to a placebo arm.
Keyword
- Faecal incontinence
- Quality of life
- Episode frequency
- Alpha-1 receptor agonist
- NRL001
Publication and Content Type
- ref (subject category)
- art (subject category)
Find in a library
To the university's database